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PurposeAn important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.MethodsThis was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post‐Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness.ResultsOf the 872 records in the EU PAS Register, 19 studies evaluating the effectiveness of RMMs were included. Eleven were cross‐sectional surveys and 8 used secondary data sources. Eighty‐nine percent (17/19) evaluated additional RMMs (used when routine RMMs are considered insufficient), and 36% (7/19) evaluated changes in routine RMMs (applicable to all medicinal products). A total of 42 effectiveness indicators were identified: 18 process and 24 outcomes. Half of the indicators (21/42) were successful; 2% (1/42) indicators were partially successful; 17% (7/42) indicators were inconclusive. Effectiveness of the remaining 31% (13/42) indicators could not be determined owing to limited information. The United Kingdom was the most frequent country for the conduct of RM effectiveness studies.ConclusionsMost of the included studies evaluated additional RMMs. Half of the effectiveness indicators (process and/or outcome) were reported as successful. This review provides evidence to support the development of future guidance on the effectiveness of RM in Europe.

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Introduction: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in people with type 2 diabetes mellitus (T2DM). The objectives of this systematic literature review were to identify and synthesize published data describing the epidemiology and mortality of CVD in the T2DM population and the associated economic burden. Methods: We conducted a systematic review searching the PubMed and MEDES databases from 2009 to 2019 using predefined selection criteria. Peer-reviewed observational studies reporting primary or secondary data on CVD prevalence, incidence, mortality, resource use and costs in patients with T2DM in Spain, written in English and Spanish, were included. Data were tabulated and summarized descriptively. Results: Of 706 articles identified, 52 were included in the review. Most studies were based on data from hospital discharge databases and registries. The reported prevalence of CVD among patients with T2DM ranged from 6.9 to 40.8%. The prevalence of coronary heart disease ranged from 4.7 to 37%, stroke from 3.5 to 19.6%, peripheral artery disease from 2.5 to 13.0%, and heart failure from 4.3 to 20.1%. Inhospital CVD mortality rates ranged from 5.6 to 10.8%. Direct costs due to CVD in hospitalized patients with T2DM were increased ([ 50%) compared with patients without CVD. No studies analysed indirect costs of CVD in patients with T2DM. Conclusions: The burden of CVD among patients with T2DM, combined with the elevated costs of care, highlights the importance of early prevention as part of integrated management of the disease to improve clinical and economic outcomes.

Introduction This study aimed to describe utilization patterns, persistence, resource utilization and costs in patients with type 2 diabetes mellitus initiating treatment with glucagon-like peptide 1 receptor agonists in routine clinical practice in Spain. Methods This retrospective study of medical records in the Big-Pac database identified adults starting treatment with once-weekly (QW) dulaglutide, exenatide-QW or once-daily liraglutide between 1 November 2015 and 30 June 2017. Patients were followed for up to 18 months from treatment initiation. Data on clinical characteristics of patients, treatment patterns, average daily dose and costs were obtained for the three cohorts. Persistence over the 18-month period was evaluated using Kaplan–Meier curves. All analyses were descriptive. Results A total of 1402 patients were included in this study (dulaglutide [ n = 492], exenatide-QW [ n = 438] or liraglutide [ n = 472]); 52.8% were men, and the mean (SD) age was 62 (11) years, glycated haemoglobin (HbA1c) was 8.1% (1.2) and body mass index was 35.5 (3.2) kg/m 2 at treatment initiation. Persistence at 18 months was 59.1% (95% confidence interval [CI] 54.8–63.4) for dulaglutide, 45.7% (95% CI 41.0–50.4) for exenatide-QW and 46.6% (95% CI 42.1–51.1) for liraglutide. The average (SD) dose was 1.2 (0.4) mg/week for dulaglutide, 1.9 (0.3) mg/week for exenatide-QW and 1.1 (0.3) mg/day for liraglutide. The average reduction in HbA1c levels at 1 year was − 0.68% for patients who initiated dulaglutide, − 0.54% for patients who initiated exenatide-QW and − 0.50% for patients who initiated liraglutide. The mean (SD) total annual health care costs were €4072 (1946) for dulaglutide, €4418 (2382) for exenatide-QW and €4382 (2389) for liraglutide. Conclusion Results suggest that patients who started treatment with dulaglutide had higher persistence over 18 months, presented lower HbA1c levels at 12 months and incurred lower annual total healthcare costs than patients who initiated exenatide-QW or liraglutide. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01039-5.

Through 2006-2015, aRMM were imposed to approximately a quarter of EU centrally authorised medicines. No time-trends were observed. Updated regulatory guidance did not appear to impact frequency of aRMM, type of interventions, or target population, however, further investigation is required. Effectiveness measurements, though increasing in time, remained limited to a minority of instances.

Introduction: To evaluate clinical inertia in patients with type 2 diabetes mellitus (T2DM), obesity and poor glycaemic control in routine clinical practice. Methods: This was a retrospective, observational study based on the analysis of medical records from the BIG-PACÒ database. Subjects who required medical care in 2013 with the following characteristics were enrolled in the study: age C 30 years, diagnosis of T2DM, glycosylated haemoglobin (HbA1c) C 8%, obesity (body mass index [BMI] C 30 kg/m 2) and treatment with C 2 oral antidiabetic drugs (OADs). Inertia was evaluated by time (days) to the first intensification during the period while HbA1c levels were C 8% and percentage of patients whose treatment was not intensified at 6 months, 1, 2 and 3 years and the end of follow-up. The minimum length of follow-up was 4 years. Descriptive analyses and Kaplan-Meier survival curves were performed. Results: A total of 13,824 patients with T2DM receiving C 2 OADs were identified; of these 2709 (19.6%) had HbA1c C 8% and BMI C 30 kg/m 2 , thus fulfilling the inclusion criteria. Of these 2709 patients, the mean age was 65.5 (standard deviation [SD] 12.0) years; 54.9% were male, mean HbA1c level was 9.2% (SD 1.3%); mean BMI was 32.1 (SD 0.9) kg/m 2 ; and mean time from diagnosis was 8.2 (SD 3.0) years. HbA1c remained C 8% for a median of 440 (95% confidence interval [CI] 421-459) days. The median time to first intensification was 456 (95% CI 429-483) days. No intensification had occurred in 77.8, 59.5, 41.5, 28.1 and 22.4% of patients at 6 months, 1, 2, 3 years and the end of follow-up, respectively. Conclusions: The patients with T2DM analysed in this study had a mean HbA1c of 9.2% at baseline, and this remained at C 8% for [ 1 year. The time to the first treatment intensification was longer than that recommended by guidelines. Treatment was not intensified in a large percentage of patients, with almost 60% of patients not receiving intensification at 1 year of follow-up.

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